{"id":32,"date":"2015-03-27T00:45:07","date_gmt":"2015-03-27T00:45:07","guid":{"rendered":"http:\/\/www.pinnacleeg.com\/iso\/iso-9001-certification-scripps-laboratories\/"},"modified":"2015-04-08T16:01:39","modified_gmt":"2015-04-08T16:01:39","slug":"iso-9001-certification-scripps-laboratories","status":"publish","type":"post","link":"http:\/\/www.pinnacleeg.com\/iso\/iso-9001-certification-scripps-laboratories\/","title":{"rendered":"Case Study &#8211; ISO 9001 Certification &#8211; Scripps Laboratories"},"content":{"rendered":"<p align=\"justify\"><strong><em>&#8220;There was great resistance before to the documentation. But now everyone is actually happy to use it. It makes their lives easier.&#8221;<\/em><\/strong><\/p>\n<p align=\"right\"><strong><em>Greg Stanton, Laboratory Manager<\/em><\/strong><\/p>\n<p align=\"justify\"><strong>Outcome:<\/strong><br \/>\nScripps Laboratories uses Pinnacle\u2019s <a title=\"Lean QMS methodology\" href=\"http:\/\/www.pinnacleeg.com\/ISO-9001-9000-Training-Consulting.php\/page\/services\/service\/quality-management-systems-QMS\" target=\"_blank\">Lean QMS\u00ae methodology <\/a>to achieve <a title=\"ISO 9001 Certification\" href=\"http:\/\/www.pinnacleeg.com\/sspqms-lean-qms-curriculum.php\/page\/services\/service\/leanqmscurriculum\" target=\"_blank\">ISO 9001 certification<\/a>, simplify processes, reduce documentation, and increase collaboration.<\/p>\n<p align=\"justify\"><strong>Industry:<\/strong><br \/>\nBiomedical, Biochemical Manufac<\/p>\n<p align=\"justify\"><strong>Objective:<\/strong><\/p>\n<ul>\n<li>Develop modern and practical quality management systems.<\/li>\n<li>Create sustainable platform for continuous improvement.<\/li>\n<li>Improve staff involvement and cooperation.<\/li>\n<li>Replace bloated library of text documentation and eliminate resistance to <a title=\"ISO 9001 Documentation\" href=\"http:\/\/www.pinnacleeg.com\/sspqms-lean-qms-curriculum.php\/page\/services\/service\/leanqmscurriculum\" target=\"_blank\">ISO 9001 documentation<\/a>.<\/li>\n<li>Regain control of the <a title=\"ISO 9001 Implementation\" href=\"http:\/\/www.pinnacleeg.com\/sspqms-lean-qms-curriculum.php\/page\/services\/service\/leanqmscurriculum\" target=\"_blank\">ISO 9001 implementation process<\/a>.<\/li>\n<\/ul>\n<p align=\"justify\"><strong>Approach:<\/strong><\/p>\n<ul>\n<li>Use Pinnacle Enterprise Group\u2019s <a title=\"Lean QMS Approach\" href=\"http:\/\/www.pinnacleeg.com\/ISO-9001-9000-Training-Consulting.php\/page\/services\/service\/quality-management-systems-QMS\" target=\"_blank\">Lean QMS\u00ae approach<\/a> to:\n<ol>\n<li>Identify and focus on key business processes,<\/li>\n<li>Efficiently manage the <a title=\"ISO 9001 Implementation\" href=\"http:\/\/www.pinnacleeg.com\/sspqms-lean-qms-curriculum.php\/page\/services\/service\/leanqmscurriculum\" target=\"_blank\">ISO 9001 implementation<\/a>, and<\/li>\n<li>Achieve <a title=\"ISO 9001 Certification\" href=\"http:\/\/www.pinnacleeg.com\/sspqms-lean-qms-curriculum.php\/page\/services\/service\/leanqmscurriculum\" target=\"_blank\">ISO 9001 certification<\/a>.<\/li>\n<\/ol>\n<\/li>\n<\/ul>\n<p align=\"justify\"><strong>Benefits:<\/strong><\/p>\n<ul>\n<li>Everyone understands key business processes, their contribution to the processes, and process interactions.<\/li>\n<li>Everyone actively participates in the management system.<\/li>\n<li>Increased productivity from improved collaboration.<\/li>\n<\/ul>\n<p align=\"justify\"><strong>ISO 9001 Certification and Lean QMS\u00ae Facilitates Collaboration<\/strong><\/p>\n<p align=\"justify\">Scripps Laboratories is a San Diego based manufacturer of proteins and immunoreagents. The company specializes in the sale of bulk quantities to the diagnostic industry and research facilities. For Scripps, the benefit of <a title=\"ISO 9001 Certification\" href=\"http:\/\/www.pinnacleeg.com\/sspqms-lean-qms-curriculum.php\/page\/services\/service\/leanqmscurriculum\" target=\"_blank\">ISO 9001 certification<\/a> was not a consideration. It was viewed as a necessary step to benefit business operations.<\/p>\n<p align=\"justify\">The company had previously implemented FDA 21 CFR 820 (QSR), a government requirement for an invitro diagnostic product which they no longer manufacture. So when competition and customer requirements directed them toward <a title=\"ISO 9001 Certification\" href=\"http:\/\/www.pinnacleeg.com\/sspqms-lean-qms-curriculum.php\/page\/services\/service\/leanqmscurriculum\" target=\"_blank\">ISO 9001 certification<\/a>, they began to work internally to implement the requirements, patterning the implementation after the FDA QSR program. In the case of Scripps Laboratories, the real business improvements are observed when comparing the company&#8217;s preconceptions and initial experiences in implementing <a title=\"ISO 9001 required documents\" href=\"http:\/\/www.pinnacleeg.com\/sspqms-lean-qms-curriculum.php\/page\/services\/service\/leanqmscurriculum\" target=\"_blank\">ISO 9001 requirements<\/a> (text based FDA QSR mode) to the quality system now used in daily operations.<\/p>\n<p align=\"justify\"><strong>Process and Documentation Misconceptions<\/strong><\/p>\n<p align=\"justify\">Because of early misconceptions of \u201cprocesses\u201d vs. \u201ctasks\u201d within a process, Scripps tended to create excessive documentation. For their 400+ products they identified 60-70 unique processes. As a small operation with a lean workforce the effort required to document and maintain these processes was such an intrusion to the business that they elected to hire a full-time employee just to create the manuals and focus on the <a title=\"ISO 9001 certification\" href=\"http:\/\/www.pinnacleeg.com\/sspqms-lean-qms-curriculum.php\/page\/services\/service\/leanqmscurriculum\" target=\"_blank\">ISO certification<\/a> project.<\/p>\n<p align=\"justify\">Even with this addition to the team, the <a title=\"ISO 9001 certification\" href=\"http:\/\/www.pinnacleeg.com\/sspqms-lean-qms-curriculum.php\/page\/services\/service\/leanqmscurriculum\" target=\"_blank\">ISO 9001 certification<\/a> project and the materials created remained disconnected from the business. &#8220;We kept hitting roadblocks,&#8221; states Gabriele Noll, a senior team member who is responsible for purchasing. &#8220;Our purchasing process was an aggregate of 10-12 pages long. The process and related forms were far too cumbersome to be used effectively,\u201d adds Noll.<\/p>\n<p align=\"justify\">It was Scripps\u2019 auditor that first referred the company to Pinnacle Enterprise Group for guidance in their implementation. Scripps\u2019 preconceptions dictated their initial response when Pinnacle President Kirill Liberman introduced his <a title=\"Lean QMS, ISO 9001 Certification\" href=\"http:\/\/www.pinnacleeg.com\/ISO-9001-9000-Training-Consulting.php\/page\/services\/service\/quality-management-systems-QMS\">Lean QMS\u00ae<\/a> to the company. &#8220;That would never work here &#8211; it&#8217;s not complicated enough,&#8221; were the kind of comments received from the Scripps team. It took several weeks of consideration while continuing to create volumes of documentation for &#8220;this might work&#8221; to become an internal directive to utilize Pinnacle\u2019s visual-based <a title=\"Lean QMS, ISO 9001 Implementation\" href=\"http:\/\/www.pinnacleeg.com\/ISO-9001-9000-Training-Consulting.php\/page\/services\/service\/quality-management-systems-QMS\" target=\"_blank\">Lean QMS\u00ae methodology<\/a>.<\/p>\n<p align=\"justify\"><strong>Fewer Processes, More Collaboration<\/strong><\/p>\n<p align=\"justify\">The first thing Pinnacle&#8217;s <a title=\"ISO 9001 certification &amp; Lean QMS\" href=\"http:\/\/www.pinnacleeg.com\/ISO-9001-9000-Training-Consulting.php\/page\/services\/service\/quality-management-systems-QMS\" target=\"_blank\">Lean QMS\u00ae<\/a> allowed Scripps to do was to discover and understand what the company\u2019s key processes really are. The result allowed Scripps to pare down their processes significantly. They went from 60-70 manufacturing processes to fewer than 10; each with 4-5 discreet functional steps.<\/p>\n<p align=\"justify\">Second, the <a title=\"Lean QMS and ISO 9001 Documentation\" href=\"http:\/\/www.pinnacleeg.com\/ISO-9001-9000-Training-Consulting.php\/page\/services\/service\/quality-management-systems-QMS\">Lean QMS\u00ae<\/a> visual documentation actually gave everyone a real understanding and visibility of the business. By using the <a title=\"Lean QMS and ISO 9001 Documentation\" href=\"http:\/\/www.pinnacleeg.com\/ISO-9001-9000-Training-Consulting.php\/page\/services\/service\/quality-management-systems-QMS\" target=\"_blank\">Lean QMS\u00ae documentation<\/a>, anyone on the Scripps team could see any process and understand how it relates to the entire business. &#8220;The visuals allow you to grasp how the processes interrelate to each other &#8211; hard to see in the text version,&#8221; comments lab manager Greg Stanton who also serves as the ISO 9001 management representative.<\/p>\n<p align=\"justify\">The most important value for Scripps in using the <a title=\"Lean QMS, ISO 9001 implementation\" href=\"http:\/\/www.pinnacleeg.com\/ISO-9001-9000-Training-Consulting.php\/page\/services\/service\/quality-management-systems-QMS\" target=\"_blank\">Lean QMS\u00ae<\/a> is found in their improved collaboration. The <a title=\"Lean QMS benefits\" href=\"http:\/\/www.pinnacleeg.com\/ISO-9001-9000-Training-Consulting.php\/page\/services\/service\/quality-management-systems-QMS\" target=\"_blank\">Lean QMS\u00ae<\/a> gives visibility to process steps that were previously available only to certain individuals.<\/p>\n<p align=\"justify\">Many of the Scripps protein purification processes contain manufacturing steps which need to be followed in specific sequences over 3-6 months or longer. Prior to the <a title=\"Lean QMS, ISO 9001 certification\" href=\"http:\/\/www.pinnacleeg.com\/ISO-9001-9000-Training-Consulting.php\/page\/services\/service\/quality-management-systems-QMS\" target=\"_blank\">Lean QMS\u00ae<\/a>, only the person involved or a person with a particular specialty or authorization knew where the products were in the process. This required them to be involved in each step. By using the operational systems developed with the <a title=\"Lean QMS\" href=\"http:\/\/www.pinnacleeg.com\/ISO-9001-9000-Training-Consulting.php\/page\/services\/service\/quality-management-systems-QMS\" target=\"_blank\">Lean QMS\u00ae<\/a>, including a newly created \u201csmart\u201d numbering system, qualified team members can step in any time to advance the products through the process.<\/p>\n<p align=\"justify\">This level of collaboration helps utilize everyone in their most productive capacity. &#8220;Everyone in the lab has now become participants rather than observers,&#8221; states Lab Manager Stanton.<\/p>\n<p align=\"justify\">Now Scripps improvements are not only recorded in the <a title=\"ISO 9001 Documentation\" href=\"http:\/\/www.pinnacleeg.com\/sspqms-lean-qms-curriculum.php\/page\/services\/service\/leanqmscurriculum\" target=\"_blank\">ISO 9001 quality management system documentation<\/a>, but are actually facilitated by the documentation. The company\u2019s continual improvements grow out of their ability to visualize the business and act efficiently using the information provided through the <a title=\"Lean QMS\" href=\"http:\/\/www.pinnacleeg.com\/ISO-9001-9000-Training-Consulting.php\/page\/services\/service\/quality-management-systems-QMS\" target=\"_blank\">Lean QMS\u00ae<\/a>. Maintaining <a title=\"ISO 9001 Certification\" href=\"http:\/\/www.pinnacleeg.com\/sspqms-lean-qms-curriculum.php\/page\/services\/service\/leanqmscurriculum\" target=\"_blank\">ISO 9001 certification<\/a> is no longer an effort or an objective; it is a byproduct of routine operations.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&#8220;There was great resistance before to the documentation. But now everyone is actually happy to use it. It makes their lives easier.&#8221; Greg Stanton, Laboratory Manager Outcome: Scripps Laboratories uses Pinnacle\u2019s Lean QMS\u00ae methodology to achieve ISO 9001 certification, simplify processes, reduce documentation, and increase collaboration. Industry: Biomedical, Biochemical Manufac Objective: Develop modern and practical [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,4,5,7,10,11,12,13,14],"tags":[],"class_list":["post-32","post","type-post","status-publish","format-standard","hentry","category-as9100","category-continual-improvement","category-iso13485","category-iso9001","category-pinnacle-enterprise-group","category-process-improvement","category-quality-management-system","category-tl9000","category-ts16949"],"_links":{"self":[{"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/posts\/32","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/comments?post=32"}],"version-history":[{"count":1,"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/posts\/32\/revisions"}],"predecessor-version":[{"id":49,"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/posts\/32\/revisions\/49"}],"wp:attachment":[{"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/media?parent=32"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/categories?post=32"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.pinnacleeg.com\/iso\/wp-json\/wp\/v2\/tags?post=32"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}